Effect of Different Dosing Regimens of Tadalafil or Tamsulosin Combined With 5α-Reductase Inhibit… (NCT07715448) | Clinical Trial Compass
CompletedPhase 4
Effect of Different Dosing Regimens of Tadalafil or Tamsulosin Combined With 5α-Reductase Inhibitors on Urinary and Sexual Outcomes in Benign Prostatic Hyperplasia
Egypt240 participants
Plain-language summary
Benign prostatic hyperplasia (BPH) is a common condition among aging men that causes lower urinary tract symptoms (LUTS) and may negatively affect sexual function. This randomized single-blind controlled clinical trial compares the efficacy, safety, and sexual outcomes of different dosing regimens of tadalafil or tamsulosin combined with 5-alpha reductase inhibitors (5ARIs) in men with BPH and enlarged prostate volume. A total of 240 participants were randomly assigned to six treatment groups and followed for 12 weeks. Changes in urinary symptoms, erectile function, ejaculatory function, prostate volume, prostate-specific antigen (PSA), urinary flow rate, post-void residual volume, and adverse events were evaluated to determine the optimal combination regimen.
Who can participate
Age range
50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male participants aged 50 years or older.
* Newly diagnosed with benign prostatic hyperplasia (BPH).
* Moderate to severe lower urinary tract symptoms (LUTS), defined as International Prostate Symptom Score (IPSS) \> 7.
* Prostate volume \>40 mL confirmed by transrectal ultrasonography (TRUS).
* Sexually active with a baseline International Index of Erectile Function-Erectile Function (IIEF-EF) score \>10.
* Prostate-specific antigen (PSA) \<4 ng/mL and no suspicious findings on digital rectal examination (DRE).
* Able and willing to provide written informed consent.
Exclusion Criteria:
* History of prostate cancer.
* Previous prostate surgery.
* Abnormal digital rectal examination suggestive of malignancy.
* Severe erectile dysfunction (IIEF-EF score ≤10).
* Uncontrolled diabetes mellitus.
* Uncontrolled cardiovascular disease.
* Neurological disorders affecting bladder function.
* Renal impairment.
* Hepatic impairment.
* Active urinary tract infection.
* Bladder stones or other significant urological pathology.
* Known hypersensitivity to tamsulosin, tadalafil, or 5-alpha reductase inhibitors.
* Patients actively seeking fertility treatment.
* Current use of medications known to significantly affect sexual function.
* Concurrent use of nitrates or contraindicated antihypertensive medications.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.